MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00504114
First received: July 17, 2007
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.


Condition Intervention
Osteoarthritis, Knee
Procedure: ACL Reconstruction Surgery
Procedure: Cartilage Resurfacing Surgery
Procedure: Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes [ Time Frame: Baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate T1rho relaxation methods and its' relation to cartilage loss [ Time Frame: Baseline, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Bone/cartilage tissue will be collected after the total knee replacement surgery. The tissue will further studied using advanced MR imaging techniques.


Enrollment: 139
Study Start Date: August 2006
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Healthy volunteers without knee pain.
2
Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2)
3
Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4).
Procedure: Total Knee Replacement
4
Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.
Procedure: ACL Reconstruction Surgery
5
Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.
Procedure: Cartilage Resurfacing Surgery

Detailed Description:

The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).

All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.

Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.

Criteria

Inclusion Criteria:

  • Healthy volunteers will have had no previous knee symptoms or surgery
  • Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
  • Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
  • Patients with acute ACL injury with associated bone contusion and bone edema
  • Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
  • Patient is willing to participate in the proposed study as evidenced by providing written informed consent.

Exclusion Criteria:

  • Current use of an investigational drug
  • Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
  • Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504114

Locations
United States, California
University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Sharmila Majumdar, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00504114     History of Changes
Other Study ID Numbers: 2R01AR046905
Study First Received: July 17, 2007
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Osteoarthritis, knee
anterior cruciate ligament
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Knee Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014